Trial to Assess Chelation Therapy 2 (TACT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.

The primary objective of TACT2, therefore, is to determine if the chelation-based strategy increases the time to the first occurrence of any of the components of the TACT2 primary endpoint: all-cause mortality, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina compared to the placebo chelation strategy.

TACT2 is being carried out to replicate the findings of TACT1, which found a striking reduction of recurrent cardiovascular events in post-MI diabetic patients receiving edetate disodium-based chelation therapy.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

50 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age: ≥ 50 years

History of diabetes, defined as medical record evidence or patient report of currently using insulin or oral hypoglycemic agents, or with a history of fasting blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or higher.

History of myocardial infarction based on the Universal Definition of MI. 36

When information about the MI hospitalization is available, all MI types except Type 2 qualify for study entry.

When information about the MI hospitalization is not available, a wall motion abnormality on imaging or a perfusion defect on scan that corresponds to a coronary distribution, whether or not accompanied by pathological Q waves in the appropriate distribution, will qualify the patient for study entry. This criterion requires a call to the CCC for case review.

Exclusion Criteria:

Baseline serum creatinine >2.0 mg/dL.

HbA1C >11%.

Myocardial infarction within 6 weeks of randomization.

History of allergic reactions to EDTA or any other components of the chelation solution, including heparin.

Coronary or peripheral arterial revascularization procedure performed within the last 6 months.

Planned revascularization procedure in the 6 months following enrollment.

Heart failure hospitalization within 6 months prior to enrollment or in clinical heart failure at the time of proposed enrollment (such as NYHA Class 3 dyspnea + rales>basilar, and additional signs of fluid overload). Such patients may be treated with diuretics and enrolled when stable.

Poor or no venous access in the upper extremities.

Prior intravenous chelation therapy within 5 years or oral chelation within 2 years of the time of proposed randomization.

Prior participation in TACT1.

Baseline platelet count <100,000.

History of cigarette smoking within the last 3 months.

ALT or AST > 2.0 times the upper limit of normal.

Wilson's disease, hemochromatosis, or parathyroid disease.

Any medical condition including a current diagnosis of cancer (except non-melanoma skin cancer) that will limit patient survival over the duration of the trial.

Any factor that suggests that the potential participant will not be able to adhere to the protocol.

Women of child-bearing potential including those with plans for post-menopausal in vitro fertilization or other reproductive technology.